Generic Danziten Availability
Last updated on Apr 10, 2025.
Danziten is a brand name of nilotinib, approved by the FDA in the following formulation(s):
DANZITEN (nilotinib tartrate - tablet;oral)
-
Manufacturer: AZURITY
Approval date: November 7, 2024
Strength(s): EQ 71MG BASE [RLD], EQ 95MG BASE [RLD]
Is there a generic version of Danziten available?
No. There is currently no therapeutically equivalent version of Danziten available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Danziten. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
-
Pharmaceutical compositions of nilotinib
Patent 10,874,671
Issued: December 29, 2020
Inventor(s): Jain; Paras P. et al.
Assignee(s): SLAYBACK PHARMA LLC (Princeton, NJ)Amorphous solid dispersions of nilotinib fumarate or nilotinib tartrate are provided, as well as pharmaceutical compositions thereof, wherein the compositions exhibit enhanced bioavailability in the fasted state. Preferably, the compositions may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., C.sub.max, AUC.sub.0-t and/or AUC.sub.0-infinity) of nilotinib, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.
Patent expiration dates:
- February 18, 2040✓
- February 18, 2040
-
Pharmaceutical compositions of nilotinib
Patent 11,793,809
Issued: October 24, 2023
Inventor(s): Jain; Paras P. et al.
Assignee(s): SLAYBACK PHARMA LLC (Princeton, NJ)Amorphous solid dispersions of nilotinib fumarate or nilotinib tartrate are provided, as well as pharmaceutical compositions thereof, wherein the compositions exhibit enhanced bioavailability in the fasted state. Preferably, the compositions may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., C.sub.max, AUC.sub.0-t and/or AUC.sub.0-infinity) of nilotinib, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.
Patent expiration dates:
- February 18, 2040✓
- February 18, 2040
More about Danziten (nilotinib)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Imprints, shape & color data
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: BCR-ABL tyrosine kinase inhibitors
- Breastfeeding
Patient resources
Other brands
Professional resources
Other brands
Related treatment guides
Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.